FDA

Once-monthly risperidone injection now approved for bipolar I disorder

October 20, 2025

On October 10, 2025, FDA approved Uzedy (risperidone) once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults.

According to a manufacturer press release, Uzedy is the first SC, long-acting formulation of risperidone that uses SteadyTeq, a copolymer technology that controls the steady release of risperidone. Patients reach therapeutic blood concentrations within 6 to 24 hours of a single dose.

Efficacy

Approval for BP-I was supported by existing clinical trial data for Uzedy, along with results from earlier studies of another long-acting risperidone injectable. These studies demonstrated that patients treated with a different risperidone formulation—administered biweekly—experienced a longer time to relapse compared with placebo recipients, whether used as monotherapy or as adjunctive therapy.

Safety

The most common adverse reactions with risperidone in patients with BD-I were weight increase (5% in monotherapy trial) and tremor and parkinsonism (≥10% in adjunctive therapy trial).

Sources:

Uzedy (risperidone) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213586s008s009lbl.pdf Revised October 2025. Accessed October 17, 2025.

FDA approves expanded indication for Uzedy® (risperidone) extended-release injectable suspension as a treatment for adults living with bipolar I disorder. [News release]. 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-uzedy-risperidone-extended-release-injectable-suspension-as-a-tre/